Cardiovascular Biomarkers and Lung Edema in Severe Burns Patients

The Role of CARdiovascular biOmarkers (NT-pro-BNP and CD146) in Predicting Lung Edema in Severely Burned Patients

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03271268

Acronym

CAROLE

Enrollment

Registered

2017-09-05

Start date

2017-08-06

Completion date

2019-04-06

Last updated

2017-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burns

Keywords

Vascular filling, Fluid overload, Biomarkers, Lung edema

Brief summary

Burn injury leads to hypovolemic then distributive shock. Fluid resuscitation remains the cornerstone of initial treatment of burn shock. However, fluid rescucitation can lead to fluid overload, which manifests most notably as lung edema. The peptide NT-pro-BNP, a biomarker of cardiac congestion secreted by the myocardium, as well as plasma CD146, an endothelial factor involved in angiogenesis and a marker of vascular congestion, may help identifying patients with risk of pulmonary edema and hypoxia . Our hypothesis is that these biomarkers may predict the occurence of pulmonary edema in severe burns patients.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Intubated mechanically-ventilated patients within the first 24 hours of admission * And/or patients with total body surface area (TBSA) burn-injured \>20 % * And/or patients with at least 10% full-thickness burns * And/or receiving vasopressors within the first 24 hours of admission * And monitored by a PiCCO system (PiCCO-2 Pulsion Medical Systems AG, Munich, Germany)

Exclusion criteria

* Admission delay to ICU \> 24 hours post burn * Age less than 18 years * Pregnancy * Chronic renal impairment with a baseline eGFR \< 15 ml/min * Patients with chemical or electrical burns * Coexisting non-burn trauma * Patients moribund on admission or dead within 72 h from admission * Patients with do-not-resuscitate orders

Design outcomes

Primary

Measure	Time frame	Description
Lung edema	During the first 7 days of admission	Extravascular lung water (EVLW) \> 10 mL/Kg as measured by transpulmonary thermodilution (TPTD)

Secondary

Measure	Time frame	Description
Hypercapnia	During the first 7 days of admission for mechanically-ventilated patients	PaCO2\> 45 mmHg
Corrected minute ventilation > 10L/min	During the first 7 days of admission for mechanically-ventilated patients	Minute ventilation × partial \[Paco2\]/40) \> 10L/min
Multiple organ dysfunction syndrome (MODS)	During the first 7 days of admission	Sequential Organ Failure Assessment score (SOFA) ≥ 8
Hypoxemia	During the first 7 days of admission for mechanically-ventilated patients	PaO2/FiO2 ratio of \<200
90-day mortality	90 days	—
Length of stay in the ICU	until 90 days of hospitalization	—
28-day mortality	28 days	—

Countries

France

Contacts

Primary ContactSabri Soussi, MD

sabri.soussi@gmail.com0613064542

Backup ContactMatthieu Legrand, MD, PhD

matthieu.m.legrand@gmail.com0685104235

Outcome results